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Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation… recallZ-2682-2020 · Boston Scientific Corporation · initiated Jun 4, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The needle surface deteriorated due to unexpected electrolysis during procedure.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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: [email protected] 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: [email protected] or can contact Sr. Regulatory Affairs Specialist at 508-683-40 or email: [email protected] regarding any questions associated with the notification. [email protected]

Recall details

Recall number
Z-2682-2020
Status
Terminated
Initiated by the company
Jun 4, 2020
Recalling firm
Boston Scientific Corporation
Quantity
205 devices
Product code
GEH
FDA submissions
K152133
Distribution
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.

Product description

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.

Code information (models, lots, serial numbers)

UPN: FPRPR3617, GTIN: 07290104831072 , Batch: A0904, A1085, A1177, A1178, A6681, A6682, A6962, A6963, A6977, A7113, U0084

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 85815).

Sources and updates

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