InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
Medical device recall Z-0267-2027. 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
- 56,331 (US); 40,211 (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 Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
56,331 (US); 40,211 (OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Codes to check against yours
3560022 UDI-DI 00763000203894 Lots VA24HE7 VA24R5J VA24TXT VA24UYB VA24WJE VA24WJF VA250XH VA25144 VA2515A VA25TEF VA25TEH VA25TEJ VA25TEL VA26A7F VA26AJA VA26AJB VA26AKS VA26AKT VA26AKU VA26AKV VA26C4T VA26CB1 VA26CB2 VA26EHL VA26EHN…
Every code shown here, 1,995 characters
3560022 UDI-DI 00763000203894 Lots VA24HE7 VA24R5J VA24TXT VA24UYB VA24WJE VA24WJF VA250XH VA25144 VA2515A VA25TEF VA25TEH VA25TEJ VA25TEL VA26A7F VA26AJA VA26AJB VA26AKS VA26AKT VA26AKU VA26AKV VA26C4T VA26CB1 VA26CB2 VA26EHL VA26EHN VA26EHP VA2725R VA2725S VA2726H VA2726J VA2728H VA2728K VA2728L VA275QE VA2760F VA277W0 VA277W1 VA27C85 VA27C86 VA27CCG VA27CEE VA27D4B VA27D62 VA27D63 VA27KEH VA27KGX VA27KHG VA27KHH VA27KHJ VA27KHK VA27KHL VA27NS0 VA27NSC VA27NSG VA27NSH VA27NSJ VA27NSL VA27ST1 VA27ST2 VA27UGK VA27UGL VA27UXN VA27UXP VA27VDZ VA27VED VA27VEE VA27VEF VA27VJF VA27VJG VA27VJJ VA27VWY VA27Y21 VA27Y22 VA27YF8 VA27YFG VA280D1 VA280E6 VA280LQ VA2848G VA28499 VA284MR VA284PJ VA284S3 VA286PS VA286PT VA2872W VA28AQH VA28BDU VA28BEW VA28BR6 VA28BR7 VA28DZR VA28E02 VA28EC2 VA28EC3 VA28GE3 VA28HC2 VA28HM9 VA28HSG VA28J1R VA28J1S VA28K8K VA28MHH VA28MHS VA28MYN VA28N0Y VA28N15 VA28N1R VA28T7D VA28T7F VA28TSM VA28TSP VA28UE7 VA28UHR VA28UHY VA28Z99 VA28ZJ5 VA28ZMP VA2976F VA297CK VA297CR VA297PV VA2990L VA29939 VA299J7 VA299J8 VA29EQE VA29EQF VA29EQG VA29EQJ VA29FSC VA29FSD VA29FSS VA29G5U VA29G94 VA29GKR VA29HCQ VA29HCU VA29HM5 VA29HM6 VA29N97 VA29QAK VA29QAL VA29QBK VA29QBL VA29QCE VA29QUW VA29QUZ VA29QVN VA29S6N VA29S6Q VA29SAV VA29SDN VA29SEY VA29SEZ VA29SF4 VA29SF5 VA29SYJ VA29Y62 VA29Y63 VA29YGH VA29YGJ VA29YKY VA29YW5 VA29Z8P VA29Z8Q VA29ZEG VA29ZN3 VA29ZSA VA29ZU3 VA29ZU4 VA29ZUG VA2A2Z3 VA2A5JQ VA2A5MK VA2A6GU VA2A6GY VA2A6L5 VA2A73R VA2A73U VA2A7EC VA2A7EF VA2A7HW VA2AEKR VA2AEM9 VA2AEWP VA2ALQ9 VA2ALUD VA2ALV0 VA2ALVA VA2ALW5 VA2APNN VA2APQA VA2APSH VA2APSU VA2ARAX VA2ARCA VA2ARCT VA2AYRR VA2AYRU VA2AYZ3 VA2AZ0W VA2AZ7J VA2AZ7R VA2B6PX VA2B8WD VA2B8WE VA2B8XZ VA2B8ZN VA2BBDN VA2BBDQ VA2BBT6 VA2BBU0 VA2BBWC VA2BBZM VA2BD21 VA2BDCD VA2BDCE VA2BHB0 VA2BHB9 VA2BHCD VA2BHCF VA2BHDU VA2BHDX VA2BHJN VA2BHPH VA2BHPK VA2BHPR VA2BUNB VA2BUNP VA2BUSW VA2BUVT VA2BXXB VA2BY1R VA2BY2N VA2BY4M VA2C4A9 VA2C4JZ VA2C582 VA2C585 VA2C7JX VA2C7LT VA2C7SB VA2CCJ0 VA2CCJ1…
FDA’s list runs to 20,044 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 20,044 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.