Recall Register

Food, drugs, devices › Firms

Abbott Medical

FDA recalling firm · 16 enforcement events · 43 product records · 2019–2026 · CA, MN

Abbott Medical has 16 FDA enforcement events on this register (43 product records) between 2019 and 2026: 16 device; the busiest year was 2024 with 7.

6% of its events are Class I; the most common class is Class II (14). 12 events are listed as ongoing; the recalling firm's address is in CA and MN.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
12 May 2026Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 softwareDeviceClass II1Ongoing
6 Oct 2025Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400DeviceClass II2Ongoing
15 Feb 2025Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart…DeviceClass II1Ongoing
21 Nov 2024The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.DeviceClass II1Ongoing
17 Oct 2024Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, SterileDeviceClass II5Ongoing
1 Oct 2024Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read device data and…DeviceClass III2Ongoing
22 May 2024Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx OnlyDeviceClass II4Ongoing
16 May 2024Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLYDeviceClass II1Ongoing
16 May 2024Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx OnlyDeviceClass II12Ongoing
5 Feb 2024Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEODeviceClass II1Ongoing
16 Aug 2023Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD REF CDVRA600Q Neutrino DR Implantable Cardioverter Defibrillator: NxT DR ICD REF CDDRA600Q Entrant VR…DeviceClass II2Ongoing
18 Jul 2023Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically…DeviceClass I7Ongoing
9 Dec 2019Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303DeviceClass II1Terminated
9 Dec 2019Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.DeviceClass II1Terminated
11 Nov 2019CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip…DeviceClass II1Terminated
14 Oct 2019Radiofrequency Grounding Pad, REF RF-DGP-LDeviceClass II1Terminated

By type and class

Device16
Class II14
Class I1
Class III1

Class I: 6% of this firm's events; 18% of all events on the register.

Events by year

19
20
21
22
23
24
25
26
Enforcement events for Abbott Medical by year initiated.

Questions and answers

How many FDA recalls has Abbott Medical had?

16 enforcement events (43 product records) on this register, 2019–2026: 16 device.

Are any Abbott Medical recalls ongoing?

12 events are listed as ongoing in the current openFDA export.

What class are Abbott Medical recalls?

14 Class II, 1 Class I, 1 Class III. 6% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.