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Terminated

Pioneer Plus Catheter PPlus 120 dual lumen device, inserted through a 6F introducer sheath and placed percutaneously into a peripheral vessel. The device tracks to its intended site in the vasculature over a standard length, commercially available 0.014" (0.36 mm) Rapid Exchange (RX) tracking guide wire. It utilizes an extendable, hollow Nitinol guide tip (needle) to facilitate the redirection and placement of a 0.014 (0.36 mm) Over the Wire (OTW) guide wire into peripheral vessels. Specification Developer: Medtronic, Minneapolis, MN. Manufactured by: Accellent, Laconia NH The Pioneer Plus Catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer Plus Catheter also provides an intra-luminal cross-sectional ultrasound image of the area of interest to facilitate placement of guide wires beyond stenotic lesions (e.g., sub-total, total or chronic total occlusions) prior to additional intervention (i.e. PTCA, stent, etc.). The Pioneer Plus Catheter is not indicated for use in the coronary or cerebral vasculature.

FDA Recall Z-0864-2011 · Posted 2011-01-06

Recalling FirmMedtronic CardioVascular
Recall StatusTerminated
Product CodeDQY
Date Initiated2010-04-30
Date Terminated2011-01-06
Product Quantity1,080 units

Reason for Recall

Needles may fail to retract and thus cause injury.

Firm Action

Medtronic sent an Urgent Medical Device Safety Information letter to all affected customers. The letter identified the product, the problem,and the action to be taken by the customer. Sales Representatives were to contact each account and complete an acknowledgement form indicating the Physicians had been notified. For questions regarding this recall customers were to contact their local representative.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - USA, Germany, Netherlands, Slovakia, and Spain

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081804PIONEER PLUS CATHETERMedtronic, Inc. · 2008-08-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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