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THD Bandy

THD SPA · Model THD Bandy · UDI-DI 08033737710685

FHN Prescription

510(k) clearances

2,058

Adverse events (8 deaths)

Recalls

Facilities

Description

THD Bandy is a disposable suction ligator for the treatment of haemorrhoidal disease, ready to use. No cleaning or disinfection required. THD Disposable comes in single packing (single use), including ligator, 4 rings, and loading system. THD Bandy connects to a suction system, while it is possible to control the quality of aspirated tissue, around which the elastic band will be released by pulling the trigger

Recalls

Date	Firm	Reason
2011-07-19	Boston Scientific Corporation	Boston Scientific has received reports where, following clip deployment, the alignment of the clip and delivery system does not allow for the withdrawal of the delivery system away
2010-09-03	Cook Endoscopy	A section of the ligator barrel may separate from the barrels friction fit adapter that attaches to the patent end of the endoscope. This could result in a section of the ligator b
2009-06-17	Boston Scientific Corporation	The clip may not deploy or, if deployed, the clip may not release from the tissue.
2009-06-17	Boston Scientific Corporation	The clip may not deploy or, if deployed, the clip may not release from the tissue.
2004-01-15	Wilson-Cook Medical Inc	Product label lacks the symbols specifying the meaning of the manufacturing and expiration date.

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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.