FDAClass IIDecember 30, 2020

IceRod" 1.5 Cryoablation Needle recall

IceRod" 1.5 Cryoablation Needle

Why was IceRod" 1.5 Cryoablation Needle recalled?

Complaint trend regarding needle shaft gas leaks.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UPN: FPRPR3203 UDIs: 07290104830198, 07290104830198, 07290104830198, 07290104830198 Batch Numbers: U0382, A6775, A1875, A0575

Product
IceRod" 1.5 Cryoablation Needle
Recalling firm
Boston Scientific Corporation
Quantity
26 units
Distribution
Nationwide
Recall date
December 30, 2020
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls