CLASS II Device recall · Reported 30 Dec 2020 · FDA Enforcement Report
IceRod" 1.5 PLUS Cryoablation Needle recalled by Boston Scientific
Boston Scientific is recalling IceRod" 1.5 PLUS Cryoablation Needle, distributed nationwide in the US. The recall was initiated on 18 Nov 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0667-2021
- FDA event ID
- 86777
- Recalling firm
- Boston Scientific, Maple Grove, MN
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 18 Nov 2020
- FDA classified
- 22 Dec 2020
- Reported
- 30 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Syringes & Needles
Timeline
| 18 Nov 2020 | Recall initiated by company | |
| 22 Dec 2020 | Classified by FDA | +34 days |
| 30 Dec 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Complaint trend regarding needle shaft gas leaks.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
IceRod" 1.5 PLUS Cryoablation Needle
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Complaint trend regarding needle shaft gas leaks.
Which lots are affected?
UPN: FPRPR3510 UDIs: 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570 Batch Numbers: U1021, U1022, U1014, U1013, U0780, U0781, U0391, U0214, U0008, A2081, A2080, A1531
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
36 other products · FDA event 86777This product is part of a recall event; the main page for the event is IceSeed" 1.5 Cryoablation Needle recalled by Boston Scientific.
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