CooperSurgical recalls H/S ELLIPTOSPHERE CATH : Incorrect bonding material may cause detachment, delaying procedures. Affected units have model 61-3005 and specific serial numbers.
Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure
CooperSurgical is recalling its H/S ELLIPTOSPHERE CATH 5 Fr catheters used in hysterosalpingography procedures. The catheter may detach during use, causing delays or complications in the procedure.
The catheter uses incorrect bonding material during assembly, which can cause parts to detach. This detachment may lead to delays in the procedure or other complications.
Healthcare providers using the catheter for hysterosalpingography or hysterosonography procedures are affected. Patients undergoing these procedures are at risk if the catheter detaches.
Check for model number 61-3005 on the catheter. Serial numbers starting with 312868 are affected. These catheters are used for hysterosalpingography procedures.
Look for model number 61-3005 on the catheter.
Contact CooperSurgical for further instructions if you have the affected model.
The affected model number is 61-3005.
Detachment may cause delays in the procedure or complications.
Check for model number 61-3005 and serial numbers starting with 312868.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0502-2024 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-0502-2024 from CooperSurgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
