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HEART XS
Aesculap AG · Model FC135SU · UDI-DI 04046964047732
GAD
Prescription
10
510(k) clearances
1,646
Adverse events (4 deaths)
44
Recalls
660
Facilities
Description
HEART XS Suture Holding Frame, flexible, (170 mm), (120 mm), diam. 18,60 mm, silicone, blue, sterile, disposable, box of 10 packagesa 2 pieces
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-05 | Integra LifeSciences Corp. (NeuroSciences) | The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 |
| 2025-04-09 | MEDLINE INDUSTRIES, LP - Northfield | Three is the potential for the retractors to puncture through the sterile packaging. |
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2024-05-17 | SEASPINE ORTHOPEDICS CORPORATION | Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure |
| 2024-05-17 | SEASPINE ORTHOPEDICS CORPORATION | Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2023-12-21 | Medagent Inc | Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which |
| 2023-05-25 | TELEFLEX LLC | There are incomplete pre-cleaning instructions within the Instructions for Use (IFU). |
| 2023-05-25 | TELEFLEX LLC | There are incomplete pre-cleaning instructions within the Instructions for Use (IFU). |
| 2022-12-08 | Medtronic Navigation, Inc. | Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection. |
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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.