Recall Z-0809-2017— Oscor, Inc.
Class II · Terminated
Class II FDA medical device recall by Oscor, Inc., initiated 2016-10-05, terminated 2019-07-26. It names 2 FDA 510(k) clearances: K122958, K101497. Product: OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.. Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use..
- Recalling firm
- Oscor, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-05
- Terminated
- 2019-07-26
- Firm location
- Palm Harbor, FL, United States
510(k) clearances named in this recall
2 on FDA's record- K122958 — DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
- K101497 — DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Reason for recall
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.