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DV8® Retractor

Manual Surgical Sciences, L. L. C. · Model 14075150 · UDI-DI 00860222000406

GAD Prescription

510(k) clearances

1,646

Adverse events (4 deaths)

Recalls

660

Facilities

Description

The DV8® Retractor Esophageal Balloon (DV8 Retractor) is a non-sterile, single-use, disposable esophageal balloon retractor. The DV8 Retractor is deployed orally and inflated inside the esophagus. The retractor gently and effectively retracts the esophagus to create a stable operating field.

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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Data 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.