—#182052

Product

Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

FDA product code: GEH — Unit, Cryosurgical, Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K152133
Affected lot / code info: UPN: FPRPR3617, GTIN: 07290104831072 , Batch: A0904, A1085, A1177, A1178, A6681, A6682, A6962, A6963, A6977, A7113, U0084

Why it was recalled

The needle surface deteriorated due to unexpected electrolysis during procedure.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Boston Scientific sent a letter dated 06/04/2020 and titled, "Urgent Medical Device Removal - Immediate Action Required" to customers regarding the IceFORCE 2.1 CX and IcePearl 2.1 CX Cryoablation Needles. The firm initiated a removal of specific lots/batches of IceFORCE 2.1 CX and IcePearl 2.1 CX Cryoablation Needles. The letter states that further distribution or use of any remaining product affected by the removal should cease immediately. Customers should verify the product lot/batch number to identify whether any product within their inventory is affected. If they have affected product in their inventory customers should respond and follow the instructions on the verification form. Customers must complete the Reply Verification Tracking Form and returned even if you do not have any of the units from the recalled lot/batch and email or fax your Reply Verification Tracking Form(s) immediately to get a Returned Goods Authorization Number (RGA #) before you return any product. Email: BSCFieldActionCenter@bsci.com or Fax to: Field Action Center 1-866-213-1806. Package/Ship the Recalled Product. Seal the box, and return to: Boston Scientific Corporation, US Distribution Center Boston Scientific Marina Bay Customer Fulfillment Center 500 Commander Shea Blvd. Quincy, Massachusetts 02171 RGA: Replacement product will be provided once affected product has been received by Boston Scientific Distributors should forward the notification to customers. Facilities that have sent products to another hospital within their network, should ensure that the notification is forwarded to them. Customers should contact their local sales representatives; email: BSCFieldActionCenter@bsci.com or can contact Sr. Regulatory Affairs Specialist at 508-683-40 or email: clara.johnson@bsci.com regarding any questions associated with the notification. BSCFieldActionCenter@bsci.com

Recalling firm

Firm: Boston Scientific Corporation
Address: 300 Boston Scientific Way, Marlborough, Massachusetts 01752-1291

Distribution

Distribution pattern: Nationwide Distribution to states of: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, KS, LA, MA, MD, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI WV, and WY and the country of: Canada.

Timeline

Recall initiated: 2020-06-04
Terminated: 2024-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182052. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.