CLASS I Device recall · Reported 3 Jan 2018 · FDA Enforcement Report
St. Jude Medical recalled by Sterilmed
Sterilmed is recalling St. Jude Medical, distributed nationwide in the US. The recall was initiated on 2 Jun 2017 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0213-2018
- FDA event ID
- 77470
- Recalling firm
- Sterilmed, Minneapolis, MN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 2 Jun 2017
- FDA classified
- 28 Dec 2017
- Reported
- 3 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 2 Jun 2017 | Recall initiated by company | |
| 28 Dec 2017 | Classified by FDA | +209 days |
| 3 Jan 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Inadequate seal due to lack of adhesive glue
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Where it was distributed
US Nationwide distribution in the states of AR, CO, FL, MI, OH, TX, and WA.
Nationwide ArkansasColoradoFloridaMichiganOhioTexasWashington
Questions about this recall
Why was it recalled?
Inadequate seal due to lack of adhesive glue
Which lots are affected?
Model No. STJ408309, STJ408310, STJ408324. Exp. Date of 05/31/2018 or PRIOR. All Lots, known lots: 7344024, 7343120, 7343643, 7343797, 7348305, 7355750, 7348712, 7290257, 7354522, 7354523, 7350001, 7324499, 7343501, 7351203, 7255673, 7273483, 7343603, 7355439, 7355745, 7355754, 7355752, 7282741, 7315539, 7320863, 7343766, 7351038, 7330645, 7345143, 7323722, 7330603, 7342081, 7351724, 7352687, 7355130, 7355131, 7355137, 7377760, 7355135, 7375662, 7404300, 7404301, 7404316, 7404306, 7343395, 7355463, 7355714, 7355622, 7330666, 7355572, 7327999, 7355677, 7308337, 7343686, 7355680, 7251903, 7259400, 7322815, 7342069, 7355574, 7355676, 7355712, 7346336, 7355666, 7355661, 7355618, 7355571, 7354437, 7350573, 7331054, 7300290, 7350792, 7355679, 7355709, 7355713, 7355681, 7355675, 7355573, 7345129, 7343838, 7355678, 7355575, 7355620, 7355711, 7346820, 7355662, 7404299, 7404282, 7404294, 7404290, 7404310, 7404311, 7404318, 7404297, 7404287, 7342672, 7357129, 7241712, 7350942, 7272027, 7316930, 7345592, 7348169, 7388731, 7372138, 7386929, 7387147
Where was it sold?
US Nationwide distribution in the states of AR, CO, FL, MI, OH, TX, and WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sterilmed
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Reprocessed Imaging Catheter Acuson recalled by Sterilmed | Sterilmed | Sterility | 8 states |
| Device | CLASS II | Catheter Acunav Diagnostic Ultrasound Not For Use recalled by Sterilmed | Sterilmed | Sterility | 8 states |
| Device | CLASS II | Reprocessed Agilis Steerable Introducer: indicated recalled by Sterilmed | Sterilmed | Device Malfunction | Nationwide |
| Device | CLASS II | Electrophysiology catheter cables are designed as electrode recalled | Sterilmed | Other | 17 states |
| Device | CLASS II | Reprocessed Microline Scissor Tips intended to be used recalled | Sterilmed | Device Malfunction | 28 states |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |