Home / Brand archive
352 reported ongoing
354 records in this archive. Latest source date Aug 6, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Class IIReported ongoing
Distribution: Nationwide including Puerto Rico Foreign: To be provided
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Class IIReported ongoing
Distribution: Nationwide including Puerto Rico Foreign: To be provided
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Class IIReported ongoing
Distribution: Nationwide including Puerto Rico Foreign: To be provided
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Class IIReported ongoing
Distribution: Nationwide including Puerto Rico Foreign: To be provided
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Class IIReported ongoing
Distribution: Nationwide including Puerto Rico Foreign: To be provided
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Class IIReported ongoing
Distribution: Nationwide including Puerto Rico Foreign: To be provided
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class IReported ongoing
Distribution: US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class IReported ongoing
Distribution: US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class IReported ongoing
Distribution: US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class IReported ongoing
Distribution: US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class IReported ongoing
Distribution: US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class IReported ongoing
Distribution: US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, KS, LA, MA, MI, MN, NY, OR, PA, TX, VA, WA and the countries of Argentina, Australia, Austria, Belgium, C...
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, KS, LA, MA, MI, MN, NY, OR, PA, TX, VA, WA and the countries of Argentina, Australia, Austria, Belgium, C...
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Class IReported ongoing
Distribution: Worldwide
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Class IReported ongoing
Distribution: Worldwide
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Class IReported ongoing
Distribution: Worldwide
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Class IReported ongoing
Distribution: Worldwide
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Class IReported ongoing
Distribution: Worldwide
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Class IReported ongoing
Distribution: Worldwide
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 354 records, including 352 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.