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Richard Wolf GmbH · Model 8955241 · UDI-DI 04055207044896

KOE

510(k) clearances

221

Adverse events

Recalls

Facilities

Description

TELESCOPE DILATOR 24FR for nephrostomy, in particular for dilating transcutaneous punctures, TL 230 mm, reusable

Recalls

Date	Firm	Reason
2019-01-04	Cook Inc.	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
2019-01-04	Cook Inc.	The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
2005-08-01	Cook Urological, Inc.	Mislabeled as to size.

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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.