Z-0864-2011

Pioneer Plus Catheter PPlus 120 dual lumen device, inserted through a 6F introducer sheath and placed...

Name: Z-0864-2011 Pioneer Plus Catheter PPlus 120 dual lumen device, inserted through a 6F introducer sheath and placed...
Creator: Medtronic CardioVascular
Published: 2010-04-30
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2010-04-30 / Terminated / root cause: manufacturing process

FDA source

Medtronic CardioVascular began a recall of Pioneer Plus Catheter PPlus 120 dual lumen device, inserted through a 6F introducer sheath and placed percutaneously into a peripheral vessel. The device... on 2010-04-30. The reason FDA records is "Needles may fail to retract and thus cause injury". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0864-2011
Status: Terminated
Initiated: 2010-04-30
Posted: 2011-01-06
Terminated: 2011-01-06
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: DQY Catheter, Percutaneous
Reason for recall: Needles may fail to retract and thus cause injury.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 1,080 units
Distribution: Worldwide Distribution - USA, Germany, Netherlands, Slovakia, and Spain
Product codes and lots: All Lots, no serial numbers.

Product code DQY

K081804Class IIPioneer Plus CatheterMedtronic, Inc. / cleared 2008-08-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)