Home › MEDTRONIC, INC. › STARFISH™
STARFISH™
MEDTRONIC, INC. · Model HP102 · UDI-DI 00643169669017
4
510(k) clearances
1,023
Adverse events (6 deaths)
17
Recalls
42
Facilities
Description
HEART POSITIONER HP102 15LA
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-12 | Medtronic Perfusion Systems | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the can |
| 2026-05-12 | Medtronic Perfusion Systems | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the can |
| 2026-05-12 | Medtronic Perfusion Systems | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the can |
| 2026-01-13 | Medtronic Perfusion Systems | During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, a |
| 2024-10-16 | Maquet Cardiovascular, LLC | Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life. |
| 2024-10-16 | Maquet Cardiovascular, LLC | Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life. |
| 2024-10-16 | Maquet Cardiovascular, LLC | Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life. |
| 2023-10-31 | Maquet Cardiovascular, LLC | The Positioner Arm may not tighten or lock during normal use. |
| 2023-09-13 | Maquet Cardiovascular, LLC | Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass gra |
| 2021-03-02 | Terumo Cardiovascular Systems Corporation | There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.