Cooper Surgical catheter recall due to component detachment risk
The Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr catheter may detach or leak due to defective bonding material used in assembly. The 73 affected units were distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is classified as High because the Class II device has potential for harm through component detachment or leakage during a medical procedure, but no illnesses or injuries have been reported.
Plain-English summary
CooperSurgical, Inc. is recalling the H/S ELLIPTOSPHERE CATH 5 Fr (Model 61-3005), a catheter used to administer contrast media during gynecological procedures such as hysterosalpingography and hysterosonography. These procedures examine the uterus and fallopian tubes for abnormalities such as polyps, fibroids, adhesions, endometrial thickening, or blocked fallopian tubes.
The recall stems from incorrect bonding material used in the catheter assembly. This defective material may fail, causing catheter component parts to detach, break, or leak during the procedure. Device failure could delay or compromise the procedure.
The recall involves 73 units with serial number 312868 (UDI-DI: 60888937016408). The devices were distributed nationwide and internationally to Belgium, Canada, Malaysia, Netherlands, Spain, Sweden, and Switzerland.
Patients and healthcare providers with these devices should contact CooperSurgical, Inc. Patients who have undergone procedures with these devices should consult their healthcare provider if they experience any complications or concerns.
The recalled product
- Product
- Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -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…
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 73
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 (1)
- UDI-DI: 60888937016408 SN: 312868
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by CooperSurgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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