Medical Catheter Set Recalled for Faulty Bonding Material
CooperSurgical is recalling H/S ELLIPTOSPHERE CATH 5 FR Sets (169 units) due to incorrect bonding material that may cause component detachment or leakage, potentially delaying diagnostic procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with risk-of-harm potential (component detachment and leakage) in a diagnostic procedure. No reported injuries or hospitalizations are mentioned in the source material; the hazard is theoretical but carries inherent risk in a gynecological device.
Plain-English summary
CooperSurgical, Inc. is recalling the H/S ELLIPTOSPHERE CATH 5 FR Set (Model 61-4005) due to incorrect bonding material used during catheter assembly. The defect may result in detachment of component parts, broken components, or leakage.
This catheter is used to administer contrast media during hysterosalpingography or hysterosonography procedures to assess uterine pathology and fallopian tube patency. If catheter components detach or leak during the procedure, the diagnostic process may be delayed. A total of 169 units are affected, with serial numbers 313121 and 313568.
The affected product was distributed nationwide and internationally to Belgium, Canada, Malaysia, the Netherlands, Spain, Sweden, and Switzerland. Healthcare providers who have received this product should discontinue use of affected units and contact CooperSurgical, Inc. Patients who have undergone or are scheduled for procedures using this catheter should consult with their healthcare provider.
The recalled product
- Product
- Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes Model: 61-40
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- component-detachment
- leakage
- equipment-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI:60888937016446 S/N: 313121
- 313568
Distribution
Distributed nationwide across the United States.
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