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Recall Observatory FDA recall evidence

Device 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: 61-3005

Z-0502-2024

March 31, 2022

Class II

Product summary

Firm
CooperSurgical, Inc.
Event
Event 93239
Status
Ongoing
Classification
Class II
Quantity
73 units
Official record key
device-enforcement:Z-0502-2024

Official wording

Reason: 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

Code information: UDI-DI: 60888937016408 SN: 312868

Distribution pattern: Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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