InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128 LEAD 978A133…
Medical device recall Z-0266-2027. Published in FDA’s Enforcement Report on Oct 28, 2026.
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 Oct 28, 2026. Copied from openFDA on Nov 4, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 94,441 (US); 60,488 (OUS) 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 II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product.
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Which ones are recalled?
InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128 LEAD 978A133 ISTM MICRO 33CM SSMRI TINED 978A133 LEAD 978A141 ISTM MICRO 41CM SSMRI TINED 978A141 LEAD 978B128 ISTM II 28CM SSMRI TINED 978B128 LEAD 978B133 ISTM II 33CM SSMRI TINED 978B133 LEAD 978B141 ISTM II 41CM SSMRI TINED 978B141
94,441 (US); 60,488 (OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Codes to check against yours
978A128 UDI-DI 00763000203603 Lots VA27EGG VA27EGJ VA27EGK VA27FKV VA27FKW VA27FKX VA27GAB VA27GAC VA27GAD VA27GAE VA27GAF VA27GAG VA27GVY VA27GXC VA27GXD VA27GXF VA27HLS VA27HLT VA27HLU VA27HLV VA27K2T VA27NK1 VA27NLY VA27QTZ VA27QUA…
Every code shown here, 1,995 characters
978A128 UDI-DI 00763000203603 Lots VA27EGG VA27EGJ VA27EGK VA27FKV VA27FKW VA27FKX VA27GAB VA27GAC VA27GAD VA27GAE VA27GAF VA27GAG VA27GVY VA27GXC VA27GXD VA27GXF VA27HLS VA27HLT VA27HLU VA27HLV VA27K2T VA27NK1 VA27NLY VA27QTZ VA27QUA VA27QUF VA27QUP VA27QUR VA27WZN VA27X01 VA27YM3 VA27YM4 VA27YMC VA27YMD VA27YMF VA27YMJ VA282HH VA282J1 VA282J8 VA282JA VA282JY VA282K0 VA282KA VA282KG VA284XZ VA2868L VA2868M VA2868P VA2868Q VA286JC VA286K5 VA286MA VA287A7 VA287AA VA287DC VA287DH VA287TD VA287X3 VA2883C VA2883E VA28845 VA2884S VA28AXJ VA28AXK VA28B2T VA28B3Q VA28B5Z VA28EQ9 VA28ETU VA28EUA VA28EUK VA28EVN VA28GUJ VA28H21 VA28H22 VA28H9T VA28H9Z VA28L7U VA28L7V VA28L7W VA28LBA VA28LBD VA28LBF VA28PRE VA28PRG VA28PRH VA28PS8 VA28PUE VA28PVK VA28QHU VA28QHV VA28QHW VA28QNK VA28QPT VA28QPU VA28U5G VA28U5J VA28U5K VA28V6V VA28V71 VA28V77 VA28V79 VA28V7A VA28V7L VA28XDH VA28XDJ VA290PU VA290PV VA290PY VA290PZ VA290Q0 VA290S5 VA297UZ VA297VE VA297VU VA298JA VA298JF VA2990B VA299MT VA29ASB VA29BW5 VA29BX3 VA29BX5 VA29BX6 VA29D8Z VA29D93 VA29D97 VA29D98 VA29D99 VA29ED5 VA29ED6 VA29ED7 VA29ED8 VA29ED9 VA29EDB VA29EHD VA29EHE VA29EN5 VA29FTM VA29FTN VA29FTQ VA29FTS VA29FTT VA29FTU VA29FV3 VA29GYL VA29GYM VA29GYN VA29GYP VA29GYQ VA29J36 VA29J37 VA29J38 VA29K6E VA29K6G VA29K6H VA29K6J VA29K6L VA29LER VA29LET VA29LEU VA29LHU VA29MHS VA29RKQ VA29RKR VA29RL0 VA29RVS VA29SLG VA29U3F VA29U3G VA29VGP VA2A15H VA2A15J VA2A15K VA2A16H VA2A16L VA2A16M VA2A16N VA2A7L1 VA2A7L2 VA2A98D VA2A98E VA2A98F VA2A98G VA2AAUK VA2AAUL VA2AAUN VA2AAUP VA2ADDK VA2AE7E VA2AGD0 VA2AGD1 VA2AGD2 VA2AGD3 VA2AGD4 VA2AGEZ VA2AH78 VA2AHNP VA2AHZZ VA2AJ00 VA2AJ01 VA2AJ03 VA2AJ11 VA2AJ1D VA2AJ1E VA2ALYL VA2ALYM VA2ALYV VA2ALYW VA2ALYX VA2ALYY VA2ALYZ VA2ALZ0 VA2ANFH VA2ANFJ VA2ANFK VA2ANFL VA2ANFP VA2ANFQ VA2AS15 VA2AS16 VA2AS17 VA2AS40 VA2AYAR VA2B6WG VA2B6WH VA2B6WJ VA2B7YF VA2B7YK VA2B7YL VA2B7YM VA2B7YN VA2B7YP VA2B7YQ VA2B9NH VA2B9Y7 VA2B9Y8 VA2B9Y9 VA2B9YA VA2B9YB VA2BA07 VA2BAKM VA2BARD VA2BARM VA2BASK…
FDA’s list runs to 73,355 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 and territory of Puerto Rico. The countries of Brazil, Colombia, Chile, Canada, Japan, New Zealand, Australia, United Kingdom, Switzerland, Sweden, Spain, Portugal, Italy, Israel, Germany, France, Finland, Canary Islands, Belgium, Austria, Norway, Northern Ireland, Netherlands, Iceland, Denmark, South Africa, Turkey, Slovakia, Saudi Arabia, Poland, Hungary, United Arab Emirates (UAE), Kuwait, Greece.
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 Sep 8, 2026.
- FDA classified it on Oct 22, 2026.
- FDA’s Enforcement Report published it on Oct 28, 2026.
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Who is recalling it?
- Medtronic Neuromodulation, of Minneapolis, 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 Nov 3, 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 73,355 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 Nov 3, 2026 and checked Nov 4, 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 Nov 4, 2026.