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Use caution Medical device recall · FDA · Published August 13, 2021

Imperative Care ZOOM 71 Reperfusion Catheter Recall: Risk of Catheter Fracture

Imperative Care recalls ZOOM 71 Reperfusion Catheters with potential for distal end fracture and detachment. Affected lots include V2014902 through F2113004. Stop using if you have these specific lots.

🇺🇸 FDA recall #Z-2577-2021Medical deviceImperative Care ›
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Recalling firmIMPERATIVE CARE INC1359 Dell Ave · Campbell, CA 95008-6609
✎ GovInfoNow plain-language explainer

Imperative Care is recalling ZOOM 71 Reperfusion Catheters that could fracture and detach at the distal end. This poses a risk of serious injury during medical procedures. Affected units have specific lot numbers listed in the recall. Read more at govinfonow.com/recall/61949-imperative-care-zoom-71-reperfusion-catheter-recall-risk-of-catheter.

Source Summary by GovInfoNow · govinfonow.com/recall/61949-imperative-care-zoom-71-reperfusion-catheter-recall-risk-of-catheter · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2577-2021

Cite this page

“Imperative Care ZOOM 71 Reperfusion Catheter Recall: Risk of Catheter Fracture.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61949-imperative-care-zoom-71-reperfusion-catheter-recall-risk-of-catheter. Based on FDA recall #Z-2577-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2577-2021%22&limit=1).

The FDA announced on Aug. 13, 2021, that Imperative Care Inc. is recalling ZOOM 71 Reperfusion Catheters due to a potential for the distal end to fracture and detach, according to the FDA.

How to tell if you have it

  • Brand: Imperative Care
  • Product: ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm)
  • UPC: 00812212030191
  • Affected Lots: V2014902, F2026201, F2026802, F2028801, F2028901, F2029501, F2029701, F2030801, F2031101, F2035301, F2032502, F2100802, F2101301, F2104102, F2108101, F2108801, F2109601, F2109701, F2111101, F2110601, F2112301, F2113004, F2112001
  • Units: 3118

The hazard

There is a potential for the distal end of the catheters to fracture and become detached, according to the FDA.

Context

GovInfoNow's records show other recent recalls of similar products include Penumbra RED 62 Reperfusion Catheter Recall (2026-07-24), Penumbra RED 68 Reperfusion Catheter Recall (2026-06-03), and Boston Scientific Imager II Angiographic Catheters Recall (2026-08-24).

How to tell if you have this one

Check the lot numbers on the catheter packaging: V2014902, F2026201, F2026802, F2028801, F2028901, F2029501, F2029701, F2030801, F2031101, F2035301, F2032502, F2100802, F2101301, F2104102, F2108101, F2108801, F2109601, F2109701, F2111101, F2110601, F2112301, F2113004, F2112001.

  • Brand
    Imperative Care
  • Product
    Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm)
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Lot Numbers

    Identify the lot numbers on your catheter packaging to see if they match the affected lots listed in the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 54 days after the firm started it.

1. Firm started the recall: Aug 13, 202112. FDA classified it Class I: Sep 29, 202123. Published in FDA’s Enforcement Report: Oct 6, 202132021
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2577-2021 (August 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2577-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA