Recall archive / FDA device enforcement
IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure ... — FDA record Z-1688-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 24, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
- Reason
- Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
- Classification
- Class II
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 244 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1688-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN 00191506032692, Batch Numbers: 33744276, 33744277, 33744278, 33744600, 33931638, 33931639, 33931900, 33980480, 33980481, 33980482, 33989380, 33989381, 33989382, 34063066, 34063067, 34063068, 34063069, 34063070, 34084080, 34084081, 34084084, 34094111, 34094112, 34110333, 34110334, 34110335, 34110336, 34110337, 34168777, 34168778, 34204925, 34204926, 34204927, 34295709. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 7, 2025
- Recall initiation date
- Mar 24, 2025
- Center classification date
- Apr 29, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.