Abbott recalls
Every recall we track for Abbott — 20 in all, from 2018–2026 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Abbott peaked in 2025 (7); 20 since 2017. 5% rated “stop using now”.
All FDA recall records for Abbott since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 1 | 0 | 2 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 2 | 0 | 2 |
| 2021 | 0 | 0 | 2 | 0 | 2 |
| 2022 | 0 | 0 | 4 | 0 | 4 |
| 2023 | 0 | 0 | 2 | 0 | 2 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 2 | 5 | 0 | 7 |
| 2026 (to date) | 0 | 0 | 0 | 1 | 1 |
What to do if you have a recalled Abbott product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Abbott recalls
14 shown- UnratedMedical device
Abbott recalls Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-018 3. 9-ACP2-007-020 4.
AbbottSep 10, 2026 - Lower riskMedical device
Abbott recalls TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Abbott recalls specific TactiFlex Sensor Enabled Ablation Catheters due to limited tip detachment events during removal from packaging. Affected units have unique batch numbers and GTIN.
AbbottSep 10, 2025 - Use cautionMedical device
Abbott recalls Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Abbott recalls specific models of Amplatzer TorqVue LP Delivery System (TVLP) due to potential small breaches causing blood loss or air embolism during procedures. Affected units include model numbers 9-TVLP4F90/060 and 9-TVLP4F90/080 with listed lot numbers.
AbbottMar 17, 2025 - Lower riskMedical device
Abbott recalls Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Abbott recalls NT2000iX RF generators with specific serial numbers due to potential capacitance failure from improper servicing. Affected units may not provide accurate results.
AbbottSep 28, 2023 - Lower riskMedical device
Abbott recalls Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Abbott recalls specific models of cardiac catheters due to reported air embolism risks during procedures. Affected units have unique batch numbers and UDI/DI codes.
AbbottJun 12, 2023 - Lower riskMedical device
Abbott recalls Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart
Abbott recalls TactiCath Sensor Enabled catheters that may show 'invalid catheter' or 'expired catheter' errors when connected to EnSite Precision Navigation System. Affected units have specific UDI and batch numbers.
AbbottJun 9, 2022 - Lower riskMedical device
Abbott recalls FIRMap" Catheter, 60mm Basket
Abbott recalls FIRMap Catheter 60mm Basket models with incorrect labeling. This may cause confusion in medical use. Affected units have specific batch numbers and expiration dates.
AbbottApr 28, 2022 - Lower riskMedical device
Abbott recalls Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Abbott recalls specific SE TactiCath Sensor Enabled Catheters due to preprogrammed first use date disabling single-use devices. Affected models include A-TCSE-DD with listed lot numbers.
AbbottMar 24, 2022 - Lower riskMedical device
Abbott recalls Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Abbott recalls a specific lot of Ultimum Hemostasis Introducer devices due to being manufactured 12 cm instead of 5 cm in length. Affected units may cause complications during medical procedures.
AbbottNov 16, 2021 - Lower riskMedical device
Abbott recalls Amplatzer Steerable Delivery Sheath
Abbott recalls specific Amplatzer Steerable Delivery Sheath models due to updated instructions for use. Affected units include batch numbers 7963817 to 8277741. Consumers should check their product details.
AbbottNov 9, 2021 - Lower riskMedical device
Abbott recalls TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN
Abbott recalls TactiCath Quartz Contact Force Ablation Catheters with model PN-004 065 and PN-004 075 due to reported loss of contact force information during use, which may affect heart procedures.
AbbottMay 22, 2020 - Lower riskMedical device
Abbott recalls Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model
St. Jude Medical recalls Merlin PCS 3650 Software Upgrade Kit (REF 3330) due to potential incorrect energy settings during device programming, which may not alert users to retained values.
St. Jude MedicalFeb 28, 2020 - Lower riskMedical device
Abbott recalls St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical
St. Jude Medical Confirm Rx Insertable Cardiac Monitor (REF DM3500) fails to pair with mobile app due to certificate expiration error. Affected units have serial numbers listed in the recall notice.
St. Jude MedicalNov 19, 2018 - Stop using nowMedical device
Abbott recalls Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for
Abbott recalls Thoratec HeartMate 3 LVAS Implant Kits (Rx Only) with serial numbers starting MLP 000976 due to reports of outflow graft twist occlusions causing persistent low flow alarms and serious health risks including hemodynamic compromise, thrombus, and death.
ThoratecApr 5, 2018
Abbott recall questions
How many recalls has Abbott had?
20 recalls from Abbott are on record with U.S. safety agencies, from 2018–2026.
What is the most recent Abbott recall?
Abbott recalls Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-018 3. 9-ACP2-007-020 4., dated Sep 10, 2026. Every Abbott recall is listed on this page, newest first.
What should I do if I have a recalled Abbott product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Abbott recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.