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Use caution Medical device recall · FDA · Published September 21, 2017

Medtronic Ascenda Catheter Recall: Risk of Kinking at Pump Connection

Medtronic recalls specific models of Ascenda Intrathecal Catheters due to potential kinking at the pump connection, which could cause drug delivery issues.

🇺🇸 FDA recall #Z-0537-2018Medical deviceMedtronic ›
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Recalling firmMedtronic Neuromodulation7000 Central Ave Ne · Minneapolis, MN 55432-3568
✎ GovInfoNow plain-language explainer

What happened, in plain English

Medtronic is recalling certain Ascenda Intrathecal Catheter models (8780, 8781, 8784) because some versions may kink near the pump connection. This could lead to improper drug delivery to the spinal canal. Read more at govinfonow.com/recall/72966-medtronic-ascenda-catheter-recall-risk-of-kinking-at-pump-connection.

Source Summary by GovInfoNow · govinfonow.com/recall/72966-medtronic-ascenda-catheter-recall-risk-of-kinking-at-pump-connection · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0537-2018

Cite this page

“Medtronic Ascenda Catheter Recall: Risk of Kinking at Pump Connection.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72966-medtronic-ascenda-catheter-recall-risk-of-kinking-at-pump-connection. Based on FDA recall #Z-0537-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0537-2018%22&limit=1).

Why it’s dangerous

The catheter may kink at the connection point to the drug infusion pump. This kink could block drug delivery to the spinal canal, potentially causing treatment failure or complications.

Who’s affected

Patients with spinal drug infusion systems using the recalled catheter models are affected. Those with the specific model numbers listed in the recall are most at risk.

How to tell if you have this one

Check your catheter model number (8780, 8781, or 8784) and the unique device identifier (UDI) listed in the recall. The catheter connects to the pump at the catheter port and enters the spinal canal.

  • Brand
    Medtronic
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Your Catheter Model

    Identify your catheter model (8780, 8781, or 8784) and unique device identifier (UDI) from the product list.

  2. Contact Medtronic

    Reach out to Medtronic directly to confirm if your catheter is affected and get instructions for next steps.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

1. Firm started the recall: Sep 21, 201712. Published in FDA’s Enforcement Report: Feb 14, 201823. FDA classified it Class III: Feb 23, 201834. FDA terminated the recall: Mar 20, 2020420172020
  1. Firm started the recall
  2. Published in FDA’s Enforcement Report
  3. FDA classified it Class III
  4. FDA terminated the recall

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-0537-2018 (September 21, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0537-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 17, 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