Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5
Medical device recall Z-3214-2026. Published in FDA’s Enforcement Report on Sep 30, 2026.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 30, 2026. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 262,686 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031 IMAGER II/5/ST/100/035 BX 5; M001314041 IMAGER II/5/BARNH/100/038 BX5; M001314051 IMAGER II/5/BERN/100/038 BX5; M001314061 IMAGER II/5/BERN/100/035 BX 5; M001314081 IMAGER II/5/BERN/40/038 BX5; M001314101 IMAGER II/5/BERN/65/038 BX5; M001314141 IMAGER II/5/H1/100/038 BX5; M001314151 IMAGER II/5/H1/100/035 BX 5; M001314301 IMAGER II/5/SIM1/65/038 BX5; M001314321 IMAGER II/5/SIM1/100/038 BX5; M001314341 IMAGER II/5/SIM2/100/038 BX5; M001314351 IMAGER II/5/SIM2/100/035 BX 5; M001314361 IMAGER II/5/SIM3/100/038 BX5; M001314521 IMAGER II/5/CHGB/65/038 BX5; M001314581 IMAGER II/5/CONTRA 2/65/038 BX5; M001314621 IMAGER II/5/C1/65/038 BX5; M001314661 00AGER II/5/C2/65/038 BX5; M001314671 IMAGER II/5/C2/65/035 BX 5; M001314761 IMAGER II/5/MIK/65/038 BX5; M001314771 IMAGER II/5/MIK/65/035 BX 5; M001314821 IMAGER II/5/SHK1.0/65/038 BX5; M001314861 IMAGER II/5/RC2/65/038 BX5; M001314881 IMAGER II/5/RDC/65/038 BX5
262,686, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
M001314001 UDI-DI 08714729354826 Batches 74B2500089 74C2600048 74E2500888 74G2500942 74H2500390 74K2400624 74K2500754 74L2400920 M001314011 UDI-DI 08714729354833 Batches 74B2500937 74F2500509 74L2400427 74L2400913 74L2500679 74M2400314…
Every code shown here, 1,997 characters
M001314001 UDI-DI 08714729354826 Batches 74B2500089 74C2600048 74E2500888 74G2500942 74H2500390 74K2400624 74K2500754 74L2400920 M001314011 UDI-DI 08714729354833 Batches 74B2500937 74F2500509 74L2400427 74L2400913 74L2500679 74M2400314 M001314021 UDI-DI 08714729354840 Batches 74A2500370 74C2500582 74E2500889 74E2600070 74G2500421 74H2500875 74K2400982 74K2500755 74L2500841 M001314031 UDI-DI 08714729354857 Batches 74B2501237 74D2600727 74F2500968 74M2400317 M001314041 UDI-DI 08714729354864 Batches 74A2500996 74B2600070 74D2501155 74D2600456 74G2500951 74K2401116 M001314051 UDI-DI 08714729354871 Batches 74A2500586 74A2500997 74B2500090 74B2500711 74B2500940 74B2501238 74B2600079 74B2600310 74B2600390 74B2600412 74B2600573 74C2501047 74C2600348 74C2600430 74C2600531 74D2500124 74D2500424 74D2501156 74D2600455 74D2600857 74D2601116 74E2500982 74E2501194 74F2500511 74F2500599 74F2500768 74G2500422 74G2500759 74G2501153 74G2501349 74H2500392 74H2500659 74H2500665 74H2501042 74J2500318 74J2500552 74K2401330 74K2500164 74K2500756 74K2500917 74L2400720 74L2500033 74L2500680 74M2400072 74M2400304 74M2400318 74M2500245 M001314061 UDI-DI 08714729354888 Batches 74A2500044 74A2500587 74A2600261 74A2600415 74B2500091 74B2500488 74B2600080 74B2600895 74C2500053 74C2500583 74C2600350 74D2500125 74D2500426 74D2600575 74E2500201 74E2500293 74E2500981 74E2501195 74F2500969 74G2500778 74G2501350 74H2501041 74J2500085 74K2400625 74K2500759 74L2400041 74L2400411 74L2400418 74L2401248 74L2401259 74L2500681 74L2500831 74L2500939 74M2400303 74M2400305 M001314081 UDI-DI 08714729354901 Batches 74A2500375 74A2600681 74B2500489 74B2600042 74B2600328 74B2600329 74C2500584 74D2500427 74E2500294 74E2501196 74E2600412 74E2600413 74F2500722 74G2500910 74G2500943 74G2501351 74H2500234 74H2501035 74K2401069 74L2400419 74L2400687 74L2500359 74L2500682 74M2400306 M001314101 UDI-DI 08714729354925 Batches 74A2500376 74A2500461 74A2600324 74A2600417 74A2600680 74B2600572 74B2600590 74B2600840 74C2500021…
FDA’s list runs to 5,432 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide - US Nationwide and territories of Puerto Rico and the countries of Albania, Algeria, Argentina, Australia, Austria, Barbados, Belgium, Brazil, Brunei Dar-es-S, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Poland, Portugal, Puerto Rico, Qatar, Rep N Macedonia, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad, Tobago, Tunisia, T¿rkiye, UAE, Ukraine, United Kingdom, USA, W. Bank Gaza Strip, Yemen.
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 24, 2026.
- FDA classified it on Sep 23, 2026.
- FDA’s Enforcement Report published it on Sep 30, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Boston Scientific Corporation, of Maple Grove, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,432 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.