Imager II 5F Angiographic Catheters, 5 units per package.
Medical device recall Z-1555-2020. Published in FDA’s Enforcement Report on Apr 1, 2020.
- 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 Apr 1, 2020. 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 for where it went
- 1068827 Single Units 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?
Potential for tip detachment of Imager II 5F Angiographic Catheters
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Imager II 5F Angiographic Catheters, 5 units per package.
1068827 Single Units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All lots of the following: 1 Material Number (UPN) Outer Package M001314041, Material Number (UPN) Inner Package M001314040 2 Material Number (UPN) Outer Package M001314051, Material Number (UPN) Inner Package M001314050 3 Material Number…
Every code shown here, 1,997 characters
All lots of the following: 1 Material Number (UPN) Outer Package M001314041, Material Number (UPN) Inner Package M001314040 2 Material Number (UPN) Outer Package M001314051, Material Number (UPN) Inner Package M001314050 3 Material Number (UPN) Outer Package M001314061, Material Number (UPN) Inner Package M001314060 4 Material Number (UPN) Outer Package M001314071, Material Number (UPN) Inner Package M001314070 5 Material Number (UPN) Outer Package M001314081, Material Number (UPN) Inner Package M001314080 6 Material Number (UPN) Outer Package M001314091, Material Number (UPN) Inner Package M001314090 7 Material Number (UPN) Outer Package M001314101, Material Number (UPN) Inner Package M001314100 8 Material Number (UPN) Outer Package M001314111, Material Number (UPN) Inner Package M001314110 9 Material Number (UPN) Outer Package M001314121, Material Number (UPN) Inner Package M001314120 10 Material Number (UPN) Outer Package M001314131, Material Number (UPN) Inner Package M001314130 11 Material Number (UPN) Outer Package M001314141, Material Number (UPN) Inner Package M001314140 12 Material Number (UPN) Outer Package M001314151, Material Number (UPN) Inner Package M001314150 13 Material Number (UPN) Outer Package M001314161, Material Number (UPN) Inner Package M001314160 14 Material Number (UPN) Outer Package M001314171, Material Number (UPN) Inner Package M001314170 15 Material Number (UPN) Outer Package M001314181, Material Number (UPN) Inner Package M001314180 16 Material Number (UPN) Outer Package M001314191, Material Number (UPN) Inner Package M001314190 17 Material Number (UPN) Outer Package M001314211, Material Number (UPN) Inner Package M001314210 18 Material Number (UPN) Outer Package M001314221, Material Number (UPN) Inner Package M001314220 19 Material Number (UPN) Outer Package M001314231, Material Number (UPN) Inner Package M001314230 20 Material Number (UPN) Outer Package M001314241, Material Number (UPN) Inner Package M001314240 21 Material Number…
FDA’s list runs to 9,427 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 distribution. US nationwide, Australia, Belgium, Brazil, Canada, Switzerland, China, Colombia, Cyprus, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Indonesia, Israel, India, Italy, Jordan, Japan, South Korea, Lebanon, Lithuania, Mexico, Malaysia, Netherlands, Norway, Poland, Russia, Sweden, Slovakia, Turkey, Taiwan, and South Africa.
These words name no state.
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 Feb 11, 2020.
- FDA classified it on Mar 25, 2020.
- FDA’s Enforcement Report published it on Apr 1, 2020.
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 9,427 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
-
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.