Abbott Medical recalls Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The…
Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
Read the official notice →- Date
- 2025-04-23
- Country
- United States
- Brand
- Abbott Medical
- Product
- Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution in the states of FL, SC, and WV and…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Abbott Medical recalls
- 2026-06-17
USAbbott Medical recalls Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
FDA · DeviceAbbott MedicalUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice →- 2025-11-19
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Abbott Medical recalls Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 .…
- 2025-01-01
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Abbott Medical recalls The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates…
Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the…
FDA · DeviceAbbott MedicalWorldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice → - 2024-12-04
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Abbott Medical recalls Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted…
Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
FDA · DeviceAbbott MedicalWorldwide - U.S. Nationwide distribution in the states of ALABAMA, ALASKA,…Official notice → - 2024-11-27
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Abbott Medical recalls Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or…
FDA · DeviceAbbott MedicalNew York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman,…Official notice → - 2024-07-31
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Abbott Medical recalls Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
FDA · DeviceAbbott MedicalWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →
Other drugs & medical recalls in the United States
- 2025-04-23
- US
Baxter Healthcare Corporation recalls Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part…
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
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Straumann USA LLC recalls TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
The devices are missing the laser marked depth markings.
FDA · DeviceStraumann USA LLCWorldwide - US Nationwide distribution in the states of CA, IN, ME, MN and the…Official notice → - US
Baxter Healthcare Corporation recalls Welch Allyn Connex Vital Signs Monitor (CVSM):
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
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GE Medical Systems, LLC recalls Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG,…
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
- US
Philips North America Llc recalls Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Potential for collimator to fall as a result of incorrect installation.
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CareFusion 303, Inc. recalls MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF:…
If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring the RxVerify Validation Code be entered/without validation…
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