CLASS II Device recall · Reported 12 Jul 2017 · FDA Enforcement Report
Electrophysiology catheter cables are designed as electrode recalled
Sterilmed is recalling Electrophysiology catheter cables are designed as electrode cables with a multi-pin, distributed in 17 states. The recall was initiated on 8 May 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2669-2017
- FDA event ID
- 77190
- Recalling firm
- Sterilmed, Minneapolis, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 May 2017
- FDA classified
- 3 Jul 2017
- Reported
- 12 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 8 May 2017 | Recall initiated by company | |
| 3 Jul 2017 | Classified by FDA | +56 days |
| 12 Jul 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP Ablation Cables because Sterilmed determined that the cables are Class III devices and thus require, but do not currently have, premarket review and approval.
Product as listed by the FDA
Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They either serve as an extension between an EP catheter and equipment out of reach or they interface an EP catheter with the appropriate external stimulation of recording equipment.
Where it was distributed
US Distribution to the states of : AL, AR, CO, FL, IL, MI, MO, MS, MT, NC, OH, PA, TN, TX, VA WI and WV.
AlabamaArkansasColoradoFloridaIllinoisMichiganMissouriMississippiMontanaNorth CarolinaOhioPennsylvaniaTennesseeTexasVirginiaWisconsinWest Virginia
Questions about this recall
Why was it recalled?
Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP Ablation Cables because Sterilmed determined that the cables are Class III devices and thus require, but do not currently have, premarket review and approval.
Which lots are affected?
all lots
Where was it sold?
US Distribution to the states of : AL, AR, CO, FL, IL, MI, MO, MS, MT, NC, OH, PA, TN, TX, VA WI and WV.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sterilmed
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|---|---|---|---|---|---|
| Device | CLASS II | Reprocessed Imaging Catheter Acuson recalled by Sterilmed | Sterilmed | Sterility | 8 states |
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| Device | CLASS II | Reprocessed Agilis Steerable Introducer: indicated recalled by Sterilmed | Sterilmed | Device Malfunction | Nationwide |
| Device | CLASS I | St. Jude Medical recalled by Sterilmed | Sterilmed | Packaging Defects | Nationwide |
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