Z-2676-2020Class II

Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1...

Name: Z-2676-2020 Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1...
Creator: Boston Scientific Corporation
Published: 2020-06-04
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2020-06-04 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for... on 2020-06-04. FDA classified it as Class II and gives the reason as "The needle surface deteriorated due to unexpected electrolysis during procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2676-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-04
Posted: 2020-07-21
Terminated: 2024-09-23
Recalling firm: Boston Scientific Corporation
Product: Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: The needle surface deteriorated due to unexpected electrolysis during procedure.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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]
Quantity in commerce: 48 devices
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 codes and lots: UPN: FPRPR3603, GTIN: 7290104831010, Batch: A1564, A1521, A6723, A6908, A6929, A7015, T0025, T0056, T0137, T0138, T0269, U0041

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2676-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2674-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-21
Z-2675-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-21
Z-2676-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-21
Z-2677-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-21
Z-2678-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-21
Z-2679-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-21
Z-2680-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-21
Z-2681-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-21
Z-2682-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-21
Z-2683-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-21

Product code GEH

K152133Class IIIcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE SystemGalil Medical , Ltd. / cleared 2015-08-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)